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临床试验/NCT06655701
NCT06655701招募中不适用

Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Presence of Stress Urinary Incontinence:

研究概览

简要总结

The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.

详细描述

One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women with DXA measurements performed within the last 6 months.
  • Based on DXA measurements:
  • Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).
  • Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.
  • Aged 50-75 years

排除标准

  • Refusal to participate in the study.
  • History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
  • Presence of psychiatric disorders.
  • Cognitive impairments.
  • Use of medications that could affect the study results.

结局指标

主要结局

Presence of Stress Urinary Incontinence:

时间窗: 0 day

Stress urinary incontinence (SUI) is the involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or lifting. In this study, the presence of SUI will be determined through a questionnaire that asks participants about symptoms and frequency of urine leakage during such activities.

Incontinence Quality of Life Scale (I-QOL):

时间窗: 0 day

The I-QOL is a validated questionnaire that measures the impact of urinary incontinence on a patient's quality of life. It assesses how incontinence affects daily activities, social interactions, and emotional well-being. Higher scores indicate better quality of life, while lower scores suggest that incontinence has a more significant negative impact on the patient's day-to-day functioning.

Skeletal Muscle Mass:

时间窗: 0 day

Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.

Handgrip Strength

时间窗: 0 day

This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.

次要结局

未报告次要终点

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

研究点 (1)

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